Enhancing Patient Safety JEFFREY J.

BORCKARDT, PhD
ANOUK L. GRUBAUGH, PhD
in Psychiatric Settings CHRISTOPHER G. PELIC, MD
CARLA KMETT DANIELSON, PhD
SUSAN J. HARDESTY, MD
B. CHRISTOPHER FRUEH, PhD

Objective. There is growing national consensus that use of institutional measures of control, such as seclusion,
restraint, enforced medications, and hand-cuffed transport, within psychiatric hospitals is all too common and
is potentially counter-therapeutic. Unfortunately, little is known about how to reduce such measures of last
resort. This article reviews the available literature and describes a proposed research agenda involving a
behavioral effort, the Engagement Model, for reducing seclusion and restraint procedures and enhancing
patient safety in psychiatric settings. Methods. Using Medline and PsychInfo, we reviewed studies that specifi-
cally evaluated efforts to reduce seclusion and restraint on psychiatric units. Key search terms included seclu-
sion, restraint, reduc*, psychiatric patient safety, psychiatric safety, psychiatric sanctuary, and quality of care
psychiatry. Results. Only very limited data are available on reducing measures of last resort and improving the
safety of psychiatric settings, and virtually no controlled data are available concerning the effectiveness of spe-
cific behavioral efforts on subsequent reduction of seclusion and restraint events. In light of the paucity of data,
we describe efforts to incorporate and evaluate such a model in a large academic psychiatric hospital using a
multiple baseline times-series design and review principles for and obstacles to implementing this model.
Conclusions. It is hoped this discussion will stimulate research on this understudied topic and provide a frame-
work for improving patient safety in psychiatric settings. (Journal of Psychiatric Practice 2007;13:355–361)

KEY WORDS: seclusion, restraint, patient safety, psychiatric settings, quality of care, engagement model

People with severe mental illnesses represent some of
the most vulnerable people in our society. As a group,
they have high rates of lifetime trauma exposure.1,2 This
problem is compounded by the fact that certain psychi-
atric experiences may recapitulate previous trauma,
exacerbating psychiatric symptoms. Seclusion and
restraint may be frightening to or violate the dignity of
patients,3 and studies have found that patients do not
like coercive institutional procedures, even when they
later acknowledge the need for involuntary commit-
ment.4–7 Thus, it is incumbent upon mental health
providers and administrators to ensure that psychiatric
settings are sensitive to the adverse consequences of
potentially frightening or traumatic experiences.
A national consensus appears to be growing that
institutional measures of control (e.g., seclusion,
restraint, enforced medications, hand-cuffed transport)
within psychiatric hospitals are both frequent and
potentially counter-therapeutic for people with mental
illnesses.3,8–13 Data also indicate that potentially harm-
ful and/or traumatic experiences within psychiatric set-
tings are common and have the potential to cause
adverse mental health consequences.11,14 The Substance
Abuse and Mental Health Services Administration,15,16
the National Association of State Mental Health
Program Directors (NASMHPD),17,18 several state men-
tal health departments,19 and others7,20 have called for
the elimination or reduction of seclusion and restraint
via legislative efforts and reconsideration of adminis-
BORCKARDT, PELIC, DANIELSON, and HARDESTY: Medical
University of South Carolina, Charleston; GRUBAUGH: Medical
University of South Carolina and Ralph H. Johnson Veterans
Affairs Medical Center, Charleston; FRUEH: at time of writing,
Medical University of South Carolina, Charleston; currently,
University of Hawaii at Hilo.
Copyright ©2007 Lippincott Williams & Wilkins Inc.
Please send correspondence and reprint requests to: Jeffrey J.
Borckardt, PhD, 518-North, IOP, 67 President Street, Charleston, SC
29425. borckard@musc.edu
We gratefully acknowledge the contributions and support for the
completion of this project provided by Joan Herbert, MS, John
Oldham, MD, and Stephen MacLeod-Bryant, MD.

Journal of Psychiatric Practice Vol. 13, No. 6 November 2007 355

Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
 ENHANCING PATIENT SAFETY IN PSYCHIATRIC SETTINGS
trative policies. It is encouraging that recent data sug-
gest it is possible to systematically reduce use of seclu-
sion and restraint,21 and that there are economic
benefits to doing so.22 For example, in 1997,
Pennsylvania’s state mental health authority became
the first to publicly commit to significantly reduce and
ultimately eliminate use of restraint and seclusion.
Within the first 5 years of the initiative, episodes of
restraint and seclusion were reduced by 74% and the
total number of hours spent by individuals in restraint
or seclusion decreased by 96%.21
Nevertheless, some researchers and clinicians have
questioned whether the goal of eliminating seclusion
and restraint entirely is clinically realistic.23 Indeed, as
we have discussed elsewhere,24 there is a central ten-
sion between maintaining safety and order on psychi-
atric units, where patients are severely mentally ill and
potentially subject to erratic and unpredictable behav-
iors, while at the same time maintaining the safety, dig-
nity, and therapeutic milieu of such psychiatric settings.
A number of behavioral efforts to enhance patient safe-
ty have been suggested,25–27 and a number of core
behavioral strategies for reducing seclusion and
restraint were recently highlighted by NASMHPD.28 In
this article, we review the empirical data on this issue,
develop a research agenda, present a behavioral model
for facilitating change, identify obstacles to implemen-
tation, and describe our current efforts to enhance
patient safety in psychiatric settings.
THE CURRENT LITERATURE
Medline and Psychinfo were searched to locate studies
that specifically evaluated efforts to reduce seclusion
and restraint on psychiatric units. Key search terms
included seclusion, restraint, reduc*, psychiatric patient
safety, psychiatric safety, psychiatric sanctuary, and
quality of care psychiatry. Based on this search, it is
clear that little is known about how to reduce such
measures of last resort and improve the safety of psy-
chiatric settings.
The review of the available literature found a number
of descriptions of administrative efforts to reduce seclu-
sion and restraint at specific psychiatric hospitals or
units that were followed by limited objective documenta-
tion of fewer episodes of seclusion or restraint.21,26,27,29–35
Similar uncontrolled pre-post and correlational studies
have also been published concerning use of seclusion and
restraint among inpatient youth.36,37 These efforts share
common themes, including commitment from adminis-
trative leaders, patient involvement, staff-education,
356 November 2007
Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
principles of behavior change, reshaping organizational
culture, and an ongoing continuous quality improvement
effort.26,28,31,38–40 While there appear to be economic ben-
efits in reducing rates of seclusion and restraint,22 ade-
quate assessment of programmatic efforts to reduce
these rates is lacking. As others (e.g., Sailas and
Wahlbeck40) have noted, evaluation of the effectiveness
of these efforts has so far not yet included adequate sci-
entific methodology. Missing from the published litera-
ture are effectiveness studies that incorporate the use of
control groups or cluster-randomized, case-control, or
time-series designs. The published research has also
focused on a relatively limited set of outcome variables
(e.g., episodes of seclusion and restraint) and it is likely
that it does not adequately represent the full range of
relevant outcome variables. It is therefore difficult at
this point to draw firm conclusions about causality con-
cerning efforts to make programmatic changes, and sys-
tematic research efforts are needed. Without data based
on systematic evaluations of the effectiveness of methods
for reducing use of seclusion and restraint, administra-
tors and managers risk expending resources to imple-
ment reduction strategies that may not have any effects
on actual rates of seclusion and restraint.
A RESEARCH AGENDA
As we implement efforts to enhance patient safety in
psychiatric settings, it is important to evaluate the suc-
cess of these efforts by examining change across a num-
ber of objective and subjective dimensions, including:
1. Frequency counts of specific events (e.g., number of
episodes of seclusion or restraint)
2. Patient perceptions, reactions, and satisfaction (e.g.,
both among those who experience seclusion and
restraint as well as among those who witness or
implement these episodes)
3. Process outcomes (e.g., use of p.r.n. medication, med-
ication adherence, attrition)
4. Clinical outcomes (e.g., length of stay, clinical
improvement)
5. Staff perceptions (e.g., employee satisfaction)
6. Objective indicators related to staff work experiences
(e.g., employee turnover, workplace injuries)
7. Variables related to cost of care.
In addition to examining these variables individually, it
would be useful to examine the relationships among
these variables (e.g., are reductions in use of seclusion
or restraint associated with improved patient or staff
satisfaction, better clinical outcomes, or reduced costs?)
Journal of Psychiatric Practice Vol. 13, No. 6
 ENHANCING PATIENT SAFETY IN PSYCHIATRIC SETTINGS
Evaluating such efforts to make changes in psychiatric
hospitals involves several significant challenges.
Measurement Challenges
Relevant variables must be identified early in the
process. For example, the degree to which patient or
staff satisfaction are relevant to issues of patient safety
is not clear. Initial research efforts need to be guided by
careful theoretical considerations and consensus among
key stakeholders regarding which variables and out-
comes are most relevant. Second, reliable and validated
instruments are not available for all domains of inter-
est, so that efforts are needed to develop and validate
such instruments.41 Third, the timing of research
assessments is critical, since different biases are likely
to operate at different time points. Patients who are sur-
veyed while still in psychiatric hospitals may feel pres-
sure not to report traumatic or harmful experiences or
low satisfaction with care; their symptom acuity while
still inpatients could also distort their perceptions of
reality. Alternatively, data collected after discharge may
be affected if significant numbers of patients are lost to
follow-up. Patients may also have varying amounts of
recall or differing perspectives on the nature and impact
of their experiences at different time points.
Design Considerations
First, the relative value of retrospective and prospective
designs must be considered. Retrospective studies can
use surveys, interviews, or focus groups to determine
frequency, perceptions, and correlates of trauma/harm
occurring within psychiatric settings. They can also be
used to examine administrative data as a rough index of
success once changes have been implemented. However,
retrospective designs cannot adequately address causa-
tion. Once hypotheses are developed, prospective stud-
ies could use time-series, case-control, dismantling
strategies, and randomized designs (e.g., effectiveness
studies using cluster-randomization or other control
groups) to obtain data on the effectiveness of behavioral
change efforts and their components. At this point,
given the lack of empirical data, we believe that initial
research efforts should include time-series designs
because they are a cost-efficient method of analysis that
allows inferences about a program’s effectiveness over
and above a placebo or Hawthorne effect. These designs
also tend to be reasonably straightforward to implement
in real-world clinical settings in which it can be difficult
to create and implement placebo-controlled conditions.42
Journal of Psychiatric Practice Vol. 13, No. 6
Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Balancing “real-world” performance improvement mod-
els with rigorous scientific methodology is challenging.
A research plan that allows the investigators to make
meaningful inferences about causality requires that one
control for competing explanations of observed effects.
The elements of a design that help us control for com-
peting explanations (e.g., randomization, control groups,
placebo or inert interventions) are obviously much easi-
er to implement in a laboratory than in a practice set-
ting. In order to systematically evaluate the effects of
different components of the model across relevant
dependent measures, we believe a time-series research
design approach should be used. This approach is often
used in clinical effectiveness trials that emphasize
external over internal validity.
Each time-series design has advantages and disad-
vantages and each is suited to answer specific research
questions. However, most designs share the fundamental
element of repeated observations over time. These obser-
vations are collected in the context of “phases” of inter-
vention and the beginnings and endings of phases can be
determined naturalistically or they can be manipulated
by the investigator. The types of inferences that can be
made from the time-series research design depend on
the methods of phase demarcation and the validity of the
interventions implemented within a phase.
One of the most powerful and flexible time-series
designs available is the multiple baseline design. This
design allows researchers to track different dependent
variables in different contexts simultaneously and sys-
tematically evaluate the effectiveness of different inter-
ventions on each of them. If the order as well as the
timing of the intervention can be randomized, some ten-
tative inferences can be made about the effectiveness of
various intervention components on dependent vari-
ables of interest. Well-conceived time-series designs can
be true experiments because they can systematically
address threats to internal validity by controlling (via
randomization) for improvement that might be due to
mere maturation, symptom variability, periodicity, his-
torical coincidence, multiple testing, and regression-to-
the-mean.43–45
Feasibility
There are likely to be many practical obstacles to con-
ducting this research. Interventions research in “real-
world” practice settings is always complicated and, in
this situation, it is further complicated by the sensitive
nature of the problem, potential barriers to implemen-
tation, and the immediate need for effective institution-
November 2007 357
 ENHANCING PATIENT SAFETY IN PSYCHIATRIC SETTINGS
al policies and procedures once need for change is iden-
tified. In addition, issues related to patient privacy,
Human Subjects protections, and the Health Insurance
Portability and Accountability Act (HIPAA) pose unique
challenges and need to be carefully addressed.
OVERVIEW OF THE ENGAGEMENT MODEL
The Engagement Model of care represents an approach
for changing the climate of psychiatric hospitals and
other inpatient facilities. Specifically, the model repre-
sents a framework for improving the therapeutic milieu
of inpatient settings in order to reduce potential
antecedents to adverse psychiatric events and the sub-
sequent need for seclusion and restraint. The critical
features and assumptions of the model 1) highlight the
importance of patients’ perspectives regarding their
psychiatric care; 2) assume that psychiatric institutions
are often coercive; 3) assume that coercive measures
may recapitulate a patient’s prior trauma; and 4)
acknowledge that staff in psychiatric facilities are often
unaware of or unequipped to handle the trauma-related
difficulties of patients. This model was inspired largely
by the work of Sandra Bloom, who has highlighted the
importance of trauma-informed care in psychiatric set-
tings.8,46 The model was then more formally developed
by staff and administrators at Salem Hospital in Salem,
Oregon. We chose to implement the Engagement Model,
as opposed to selecting a different set of initiatives or
even developing our own model, because there were
some promising preliminary reports supporting its
effectiveness,8,34,38,47 and the leadership of the Institute
of Psychiatry (IOP) at the Medical University of South
Carolina (MUSC) agreed with the principles on which it
is based.
Three principles are considered critical factors in suc-
cessfully implementing the model:
Changes to the environment include basic structural
changes as well as general changes in the climate of
care in psychiatric settings that will foster a sense of
community and safety for patients. Patient care
areas can be de-institutionalized with minor changes
such as the addition of comfortable furniture, neat
surroundings, pleasant lighting, plants, or soft
music. Environmental signs such as “seclusion
room,” code words such as “take-downs,” and patient
safety terms such as “security check” can be rela-
beled or eliminated altogether to de-emphasize
measures that might be perceived as punitive. Such
changes foster an environment of care rather than
one of institutional containment.
358 November 2007
Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Patient involvement in treatment planning involves a
“teamwork” approach to each patient’s care. Patients
are involved in their own treatment planning as well
as in caring for the hospital community. A group
atmosphere is fostered through community meetings
in which patients and staff openly discuss how to han-
dle disruptions and inappropriate behavior. Patients
are held accountable for their behavior, and disrup-
tions to the therapeutic environment are viewed as
affecting the community rather than just the individ-
ual. When incidents of seclusion occur, subsequent
debriefing occurs at both the individual and commu-
nity level. Although the inherent power differential of
the psychiatric setting is acknowledged, perceptions
of randomness are dispelled through clear communi-
cation regarding acceptable and unacceptable com-
munity behavior.
Trauma-informed care emphasizes the importance of
educating both patients and staff about relevant trau-
ma-related issues. Patients are encouraged to consid-
er how their trauma histories influence their
perceptions and reactions to care. The goal of trauma-
informed care is to ensure that institutional proce-
dures do not re-expose patients to experiences that
will recapitulate their traumatic histories. Thus, psy-
chiatric advance directives or risk management
approaches for managing disruptive behavior are
encouraged to give patients a sense of control and to
facilitate problem solving regarding strategies to
reduce distress.48 At both the staff and patient level,
trauma-informed care means remaining cognizant of
the role of trauma in the psychiatric setting.
Empirical Evidence for the Engagement Model
Implementation of the concepts in the Engagement
Model may represent a unique opportunity to improve
patient care. However, there are virtually no formal
data concerning the success of this model In 2001,
Salem Hospital initiated a new environment of care in
an effort to dramatically reduce the number of incidents
of seclusion and restrain on their psychiatric unit.
Guided by the work of Sandra Bloom,8,46 the implemen-
tation of the model at Salem Hospital stressed a para-
digm shift from an environment of restriction and
containment to one of flexibility and active patient
engagement in the treatment process. Between 2000
and 2002, Salem Hospital reported an 87% reduction in
the incidence of seclusion and restraint and a 50%
reduction in overall time in seclusion.38 Since 2002,
Salem Hospital has essentially eliminated the use of
Journal of Psychiatric Practice Vol. 13, No. 6
 ENHANCING PATIENT SAFETY IN PSYCHIATRIC SETTINGS
seclusion, with no reported incidents of seclusion in the
past few years.47 In addition, informal estimates by
quality and outcomes administrative staff at Salem
Hospital suggest that there has been a reduction in use
of p.r.n. medication, improved staff satisfaction, and
decreased staff turnover.49 Research is needed, however,
to test the effectiveness of the model and its components
more formally.
CHALLENGES IN IMPLEMENTING THE
ENGAGEMENT MODEL
Although the Engagement Model represents a promis-
ing new approach to patient care, several practical chal-
lenges arise in implementing the model. For example,
higher costs are likely on the front end. The cost of
training staff, lost productivity time due to training, fees
for outside consultations, need for higher staffing ratios
with more 1:1 staff to patient interactions, and neces-
sary structural environmental changes are potentially
significant. Although the model could ultimately prove
to be more cost-effective (e.g., due to reduced length of
stays, reduced use of medications, fewer legal actions),
this has yet to be demonstrated. In a healthcare climate
in which most organizations are reducing budgets,
incorporating changes can be daunting. Implementing
this model of care also requires a substantial cultural
change and ongoing staff education. It is likely to be
challenging to get experienced staff to view treatment in
a different way. Also problematic could be the frequent
use of “pool staff” and the constant flux of trainees at
some institutions. Finally, there may be challenges to
implementing the model across different patient popu-
lations due to characteristics of the disorders being
treated in different programs within the same hospital
(e.g., dementia, severe psychosis, acute alcohol and drug
intoxication).
Implementing the Model at the Medical
University of South Carolina
In early 2006, hospital administration at the IOP at
MUSC decided to initiate efforts to reduce seclusion and
restraint and improve patient safety on all inpatient
units. These efforts involved a site-visit and consulta-
tion regarding the Engagement Model of care from staff
and administrators at Salem Hospital in Salem,
Oregon. It was determined that three general categories
of changes would be implemented: 1) staff education and
training, 2) changes to the physical environment, and 3)
changes aimed at increasing patient involvement in
Journal of Psychiatric Practice Vol. 13, No. 6
Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
treatment planning. An Engagement Model research
subcommittee was formed to evaluate the effectiveness
of the different components of the model during this
change process and to consult with the implementation
teams about how to maximize meaningful inferences
about causality.
We decided to implement a modified multiple-base-
line design. Since the IOP/MUSC has five different
inpatient units and the Engagement Model involves
three distinct elements, each element can be imple-
mented at randomly determined times independently
on different units. For example, randomization methods
can be implemented so that environmental changes will
be made on Unit 1 at week 3, Unit 2 at week 12, Unit 3
at week 25, Unit 4 at week 16, and Unit 5 at week 7.
Customized questionnaires can be administered to all
staff and patients on all units after each individual
unit’s environmental changes. Thus, at week 3, we
hypothesize that there will be a significant change in
staff and patient perceptions of the environment on
Unit 1, but no change on this dimension on any of the
other units. We might also expect a significant increase
in patient satisfaction following implementation of this
change on Unit 1, which would not be found on the
other units. If a pattern emerges showing that each
environmental implementation on each unit is followed
by a change in environmental perceptions and increas-
es in patient satisfaction on that unit but not on the
others, some tentative causal inferences can be made
about the effects of general environmental changes on
patient satisfaction. However, to the extent that sever-
al environmental changes will likely be made at once on
each individual unit, we will not be able to determine
which specific environmental change was associated
with the largest change in environmental perceptions
or satisfaction.
This same logic will be applied to the implementation
of staff training concerning provision of trauma-
informed care and changes in policies and procedures
related to patient involvement in treatment planning.
While many of the changes that will be made during
the implementation of the Engagement Model will be
executed simultaneously, at minimum, we intend to
maintain separation between the interventions reflect-
ing each of the three main categories described above.
Whenever possible, we will also try to include further
separation of interventions within categories. For
example, we might be able to provide staff training in
two separate sessions and could then conceivably exam-
ine our dependent measures a few weeks after the first
training session and again after the second training
November 2007 359
 ENHANCING PATIENT SAFETY IN PSYCHIATRIC SETTINGS
session. If each session is associated with unique sig-
nificant change in the relevant outcome measures, we
may be able to make inferences about the importance
and impact of each training module. Similarly, if only
one of the training sessions is associated with improve-
ment across all units, we may be able to make infer-
ences and/or recommendations about the necessity of
including both training modules. We will not, of course,
be able to determine which elements of each individual
training session are most influential. Nevertheless, the
more we can break down and compartmentalize each
intervention into its basic units, the better we will
understand the most potent elements of the model.
Internal validity of the interventions will be gauged by
post-intervention-phase testing of unit staff to deter-
mine how well they have learned and implemented the
ideas unique to the goals of the phase in question.
We anticipate some potential problems with the
implementation of the research model at the IOP. Some
problems might arise related to staff “floating” from unit
to unit. Occasionally, IOP staff may provide coverage on
different units at different times within a shift. As the
units may be at different places with respect to the roll-
out process over time, “cross-pollination” may threaten
the internal validity of the study. However, staff are
instructed to respect the engagement progress and indi-
vidual climate of each unit, and they are instructed not
to introduce concepts and interventions from their base
unit onto other units.
Another potential problem is that the individual units
at the IOP provide services to different patient popula-
tions, and this may confound results regarding the effec-
tiveness of the various interventions. We believe,
however, that if the effects of implementing the model
are reasonably robust, we should be able to detect
changes across at least some of the proposed dependent
measures despite some heterogeneity in patient popula-
tions between units. Additionally, unit staff will be com-
pleting a standardized post-test after the roll-out of
each component that measures knowledge and skills
related to the entire engagement model. We expect that
staff should score well on sections that address content
related to their current phase of the roll-out and score
less well on sections related to phases to which they
have not yet been exposed. This will provide us with
some data regarding the internal validity of the study
design and allow us to quantify the degree of “cross-pol-
lination.” All of the data will be monitored throughout
the study by a small group of researchers to ensure that
none of the interventions is associated with significant
decreases in patient safety. See Hardesty et al. 200750
360 November 2007
Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
for more details on the administrative and managerial
considerations of the engagement model roll-out.
The research plan described here is imperfect. Unlike
tightly controlled clinical trials, we will not be able to
rule out all viable competing explanations for observed
effects. However, we believe that this plan strikes a rea-
sonable balance between the limitations imposed by
real-world operational performance improvement proj-
ects and rigorous scientific endeavors. In reviewing the
elements of the Engagement Model of care, as well as
our own process of developing and implementing the
model on our psychiatric inpatient units, we hope that
we have provided a framework of care that other clini-
cians and researchers can adopt and refine. Ultimately,
we hope that our work will stimulate further discussion
and interest in changing the climate of care on inpatient
psychiatric units, thus protecting some of the most vul-
nerable members of our society. Formal results from this
study are expected to be available in the spring of 2008.
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